Abbott Humira
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Abbott's lead project, TNF-alpha inhibitor Humira (adalimumab, D2E7), clears FDA Dec. 31 for reducing signs and symptoms and inhibiting the progression of structural damage in adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more disease-modifying anti-rheumatics. Abbott is highlighting convenience of once-weekly dosing, efficacy in reducing structural joint damage and price to encourage switching RA patients from Amgen/Wyeth's Enbrel (etanercept) and J&J's Remicade (infliximab). Enbrel and Remicade carry more indications; Abbott plans to begin filing for five additional indications in 2004. Supply of the biologic is adequate, Abbott say